Intervention for Alcohol Use Disorder Recovery After Liver Transplantation

NCT ID: NCT07214259

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-31

Study Completion Date

2028-08-31

Brief Summary

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The goal of this clinical trial is to learn if it is feasible and acceptable to use a recovery coach and an online sober active community to help with alcohol use disorder after liver transplant. The main questions it aims to answer are:

* Is using a recovery coach after liver transplant to help with alcohol use recovery feasible and acceptable?
* Is using an online sober active community after liver transplant to help with alcohol use recovery feasible and acceptable? Researchers will compare standard of care including a recovery coach alone to a recovery coach plus to assist with recovery from alcohol use recovery after liver transplant

Participants will:

* Work with a recovery coach including a weekly phone call
* Visit the clinic once every 3 months for a checkup and to complete surveys
* If randomized to the intervention arm, download an online application with access to a digital sober active community

Detailed Description

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Rates of alcohol use disorder and alcohol associated liver disease requiring liver transplantation continue to rapidly rise. Return to alcohol use after liver transplant is associated with increased rates of liver transplant failure and mortality, but there is no evidence-based integrated intervention to address alcohol use disorder in liver transplant recipients. The goal of this pilot feasibility randomized control trial is to address a critical gap in knowledge and care for liver transplant recipients with concurrent alcohol use disorder by developing and pilot testing an integrated liver transplant and alcohol recovery program (ILTARP) consisting of a recovery coach supporting post-transplant alcohol relapse prevention, outreach, and care coordination with the added intervention of access to an active sober community. The investigators will conduct a pilot feasibility study of the newly developed ILTARP intervention testing feasibility, acceptability, and potential effectiveness of ILTARP in the liver transplant clinical setting.

Conditions

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Liver Transplant Recipient Alcohol Use Disorders (AUD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

The participants in the control arm will work with a recovery coach and have weekly phone calls with the recovery coach. They will visit the clinic every 3 months for an in-person visit and to complete survey measures related to the study.

Group Type ACTIVE_COMPARATOR

Recovery coach

Intervention Type BEHAVIORAL

Participants will work with a recovery coach including having weekly phone calls with that recovery coach.

Intervention

The participants in the intervention arm will work with a recovery coach and have weekly phone calls with the recovery coach. They will also have access to an online sober active community that they can use to augment their recovery process. They will visit the clinic every 3 months for an in-person visit and to complete survey measures related to the study.

Group Type EXPERIMENTAL

Online Sober Active Community

Intervention Type BEHAVIORAL

Participants will have access to an online sober active community that they can use to augment their recovery process.

Recovery coach

Intervention Type BEHAVIORAL

Participants will work with a recovery coach including having weekly phone calls with that recovery coach.

Interventions

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Online Sober Active Community

Participants will have access to an online sober active community that they can use to augment their recovery process.

Intervention Type BEHAVIORAL

Recovery coach

Participants will work with a recovery coach including having weekly phone calls with that recovery coach.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 21 years old
* Recipient of liver transplant less than or equal to 5 years ago
* History of alcohol use disorder
* Able to understand the purpose of the study and willing to participate and sign informed consent
* Has a smart phone to use for contact with recovery coach and the digital sober active community without additional personal cost
* Willing to participate in online digital community

Exclusion Criteria

* Liver transplant recipient for reason other than alcohol associated liver disease
* Liver transplant greater than 5 years ago
* No mechanism for regular phone contact
* No ability to utilize an application for a digital sober active community
* Any condition that in the opinion of the PI introduces undue risk by participating in this study
* less than 21 years of age
* no history of alcohol use disorder
* Any condition that in the opinion of the PI introduces undue risk by participating in this study
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Leigh Anne Dageforde

OTHER

Sponsor Role lead

Responsible Party

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Leigh Anne Dageforde

Associate Professor of Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Central Contacts

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Leigh Anne Leigh Anne Dageforde, MD, MPH

Role: CONTACT

615-322-5000

Other Identifiers

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K23AA031068

Identifier Type: NIH

Identifier Source: secondary_id

View Link

251447

Identifier Type: -

Identifier Source: org_study_id

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